21 CFR 890.5360
Measuring exercise equipment
21 CFR 890.5360 is the regulation titled “Measuring exercise equipment” in 21 CFR Part 890, Physical Medicine Devices. Since 2021, 2 FDA warning letters have cited it.
- Letters citing it
- 2 since 2021
- Jan 1 to Oct 30, 2026
- 0 against 2 on the same dates in 2025
- Most often cited with
- 21 CFR 807.81, in 2 letters
- Closed out
- 0% of these letters have a published close-out
Letters citing it, by year issued
All are medical device letters. 2026 runs to Oct 30, 2026. Pick a year to see its letters.
- 02021
- 02022
- 02023
- 02024
- 22025
- 02026
The regulation
Read the text of 21 CFR 890.5360 (eCFR, as of Sep 1, 2026)
(a) Identification. Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.
(b) Classification. Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.
[48 FR 53047, Nov. 23, 1983, as amended at 84 FR 71818, Dec. 30, 2019; 85 FR 44188, July 22, 2020]
Text from eCFR as of Sep 1, 2026.
Cited alongside it
Regulations that appear in the same letters as 21 CFR 890.5360.
- 21 CFR 807.81When a premarket notification submission is required2 letters cite both
- 21 CFR 820.100Corrective and preventive action2 letters cite both
- 21 CFR 820.198Complaint files2 letters cite both
- 21 CFR 820.22Quality audit2 letters cite both
- 21 CFR 820.25Personnel2 letters cite both
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1 letter cites both
- 21 CFR 820.20Management responsibility1 letter cites both
- 21 CFR 820.30Design controls1 letter cites both
Latest letters citing it
The 2 letters citing 21 CFR 890.5360 that FDA posted most recently.
- DevicesView SeniorLife Technologies, Inc.SeniorLife.AIIssuedAug 21, 2025PostedSep 16, 2025
- DevicesView Exer Labs, Inc.Exer ScanIssuedFeb 10, 2025PostedMar 25, 2025
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Counts include every citation in a letter, as the Letters filter does. How this database is built.